Key Takeaways:

• What Happened: FDA announced temporary relief from certain premarket regulatory requirements pertaining to certain new or modified medical devices intended for use against the novel coronavirus.
• Who’s Impacted: Manufacturers and distributors of certain medical sanitizers, disinfectant devices, and air purifiers.
• What Should They Consider Doing in Response: Manufacturers may be able to bring covered new or modified medical devices to market more quickly while the policy remains in effect.
• By When Should They Act: The temporary policy will remain in effect for the duration of the COVID-19 public health emergency.

Manufacturers of sterilizers, disinfectant devices, and air purifiers used in medical settings to combat the COVID-19 pandemic now have greater regulatory flexibility, thanks to new enforcement guidance from the Food and Drug Administration (FDA).

The covered products include those intended to sterilize or disinfect certain medical devices, or to kill or remove pathogens from the air. While the enforcement policy is in effect, FDA intends to allow limited modifications to the indications or functionality of such devices that have already been approved by FDA, as well as distribution or use of such devices that have not yet received FDA pre-market approval.

The new policy is effective immediately. It will remain in effect for the duration of the public health emergency announced by the Department of Health and Human Services on January 31. FDA’s policy complements similar steps taken separately to facilitate the manufacture and availability of hand sanitizers.

1. Background

Under the Federal Food, Drug and Cosmetic Act (“FFDCA”), manufacturers of certain sterilizers, disinfectant devices, and air purifiers are subject to FDA premarket requirements for medical devices. For new or high-risk devices, manufacturers must submit a premarket approval application (“PMA”). For devices similar to those that FDA has previously approved, manufacturers must submit a premarket notification under FFDCA § 510(k). In both cases, after FDA approves or clears these devices, premarket FDA approval is generally required for modifications to the indications or functionality of the devices.

The sterilizers, disinfectant devices, and air purifiers covered by FDA’s COVID-19 enforcement policy are all regulated as “medical devices” under the FFDCA:

• Sterilizers and high-level disinfectants used on critical or semi-critical medical devices and other FDA-regulated disinfectant devices. 
• Air purifiers intended for medical purposes to kill pathogens in the air by exposure to UV radiation or to remove such pathogens through filtration.

Note that many hard surface chemical disinfectants and non-medical devices making antimicrobial claims are separately regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) by the Environmental Protection Agency (“EPA”). For more information on recent steps taken by EPA in connection with these products, please see our alert available here.

2. Enforcement Discretion During COVID-19 Emergency

FDA’s new enforcement policy allows manufacturers to make limited modifications to the indications or functionality of previously approved sterilizers, disinfectant devices, or air purifiers, so long as the modifications pertain to the device’s effectiveness against the novel coronavirus. 

The policy also covers the distribution and use of sterilizers, disinfectant devices, or air purifiers that are intended to be effective at killing the novel coronavirus but do not already have premarket authorization. FDA is taking this action because it sees the novel coronavirus, SARS-CoV-2, as among the least resistant to these kinds of devices, due to its size and envelopment in a lipid bilayer. The policy applies only to products intended to sterilize or disinfect medical devices, or to kill or remove pathogens from the air. It explicitly does not apply to products intended to prevent or reduce the risks of hospital-acquired infections or COVID-19 in human beings. 

For the duration of the public health emergency related to the COVID-19 pandemic, FDA “does not intend to object” to limited modifications to the indications or functionality of specific FDA-cleared or FDA-approved sterilizers, disinfectant devices, and air purifiers pertaining to a device’s virucidal effectiveness against the novel coronavirus, without compliance with the regulatory requirements listed below, where such devices do not create an undue risk in light of the current pandemic:

• Prior submission of a premarket notification under FFDCA § 510(k) and 21 C.F.R. § 807.81.
• Prior submission of a PMA Supplement under FFDCA § 515 and 21 C.F.R. § 814.39.
• Registration and Listing requirements in 21 C.F.R. Part 807.
• Unique Device Identification requirements in 21 C.F.R. Part 830 and 21 C.F.R § 801.20.

FDA believes that such devices will not present an undue risk where manufacturers meet certain performance and labeling recommendations to ensure product effectiveness and help users to better understand the new devices or device modifications. It recommends that manufacturers follow specified consensus standards for product design, evaluation, and performance validation for different types of sterilizer, disinfectant device, and air purifier distributed under the temporary policy. Additionally, FDA recommends that manufacturers include at least the following label statements in the labeling for such devices:

• A clear description of the available data on the device’s new indications or functions related to SARS-CoV-2;
• A clear distinction between FDA-cleared or FDA-approved indications and those that are not FDA-cleared or FDA-approved, as well as a general statement about changes made without FDA clearance;
• For all disinfectant devices, a clear statement of the level of disinfection; and
• For UV disinfecting devices, a caution about the effectiveness and use of such devices as an adjunct to existing reprocessing practices, appropriate UV hazard warning and dosage labeling, instructions for use, and various other label statements.

Manufacturers must also document all changes to their devices in their device master records and change control records, and must make this information available to FDA upon request.

According to FDA, examples of devices to which the new policy would apply include a pre-cleared steam sterilizer for which the manufacturer would like to include a labeling statement of effectiveness in killing the novel coronavirus, and a new medical air purifier that is effective in filtering out dust particles and bacteria and for which the manufacturer would like to modify the filter mesh size in order to filter out viruses.